§ 379v. Safety report disclaimers

214 words·~1 min read·/usc/title-21/section-379v

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With respect to any entity that submits or is required to submit a safety report or other information in connection with the safety of a product (including a product that is a food, drug, device, dietary supplement, or cosmetic) under this chapter (and any release by the Secretary of that report or information), such report or information shall not be construed to reflect necessarily a conclusion by the entity or the Secretary that the report or information constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death, serious injury, or serious illness.

Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or caused or contributed to a death, serious injury, or serious illness.

(June 25, 1938, ch. 675, § 756, as added Pub. L. 105–115, title IV, § 420, Nov. 21, 1997, 111 Stat. 2379.)

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U.S. Code

statutes-at-large

Public Law 105–115
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes

Traces to 1 document

U.S. Code

Definitions; generally
§ 321

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June 25, 1938, ch. 675, § 756
Pub. L. 105–115, title IV, § 420
111 Stat. 2379
section 501 of Pub. L. 105–115

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cites case law

§ 379v

Safety report disclaimers

U.S.C.×4

Stat.×1

U.S.C.§ 321

ActJune 25, 1938, ch. 675, § 756

Pub. L.Pub. L. 105–115, title IV, § 420

Stat.111 Stat. 2379

Pub. L.section 501 of Pub. L. 105–115

Cites 5Cited by 5 across 2 sources